Effects of NMDA-receptor antagonism on hyperalgesia, opioid use, and pain after major surgery in young and elderly patients
| ISRCTN | ISRCTN64506738 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN64506738 |
| Secondary identifying numbers | MCT-52682 |
- Submission date
- 26/09/2005
- Registration date
- 26/09/2005
- Last edited
- 11/12/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Lucia Gagliese
Scientific
Scientific
Department of Anaesthesia
Toronto General Hospital
200 Elizabeth Street
Toronto
M5G 2C4
Canada
| Phone | +1 416 340 4296 |
|---|---|
| lucia.gagliese@uhn.on.ca |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Our primary aim is to determine whether perioperative NMDA-receptor antagonism has differential effects on postoperative pain, hyperalgesia and morbidity in younger and older patients. In order to achieve this aim, we propose to conduct the first randomized, double-blind placebo-controlled study designed to investigate age differences in the effects of perioperative oral administration of an NMDA-receptor antagonist (amantadine) in men undergoing radical prostatectomy. In addition, age differences in psychosocial factors and the pharmacological properties of amantadine and morphine will be measured to control for, and clarify, their contribution to the differences found. |
| Ethics approval(s) | Ethics approval received from the University Health Network Research Ethics Board, Toronto, Ontario on the 12th November 2003. |
| Health condition(s) or problem(s) studied | Postoperative pain in radical prostatectomy |
| Intervention | Amantadine versus Placebo comparison. Trial details received: 12 September 2005 |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Amantadine |
| Primary outcome measure | Hyperalgesia and opioid consumption. |
| Secondary outcome measures | Assess age differences in the intensity and course of secondary hyperalgesia after surgery. |
| Overall study start date | 01/04/2002 |
| Completion date | 31/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target number of participants | 132 |
| Key inclusion criteria | 1. Able to read and write English 2. Age 18 - 54 years or greater than 55 years, male 3. American Society of Anesthesiologists (ASA) class 1 to 3 4. Scheduled for elective radical prostatectomy 5. Body weight between 60 and 90 kg, Body Mass Index (BMI) less than or equal to 30 |
| Key exclusion criteria | 1. Significant Central Nervous System (CNS), respiratory, cardiac, hepatic, renal or endocrine dysfunction and/or any significant sequelae 2. Contraindications allergies to, and/or past adverse reactions to opioid analgesics or amantadine 3. History of Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) axis I disorder or cognitive dysfunction 4. History of epilepsy or other seizures 5. History of chronic pain of at least 6 months duration 6. History of long-term opioid use for chronic pain 7. History of long-term use of amantadine or other antiparkinsonian drug 8. Ingestion of antiussive medication within 48 hours before surgery 9. History of alcohol or drug dependency/abuse of at least 6 months duration |
| Date of first enrolment | 01/04/2002 |
| Date of final enrolment | 31/12/2006 |
Locations
Countries of recruitment
- Canada
Study participating centre
Department of Anaesthesia
Toronto
M5G 2C4
Canada
M5G 2C4
Canada
Sponsor information
University Health Network, Toronto (Canada)
University/education
University/education
200 Elizabeth Street
Toronto
M5G 2C4
Canada
| kfibiger@uhnres.utoronto.ca | |
| Website | http://www.uhnresearch.ca |
"ROR" |
https://ror.org/026pg9j08 |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-52682)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
